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Aceclidine-based presbyopia eye drop
August 6, 2025
LENZ Therapeutics Inc. announced that the US Food and Drug Administration approved VIZZ (aceclidine ophthalmic solution) 1.44%, which LENZ describes as “the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.”
Product Availability and Commercial Plans
Samples are anticipated in the United States as early as October 2025, with broad commercial availability expected by mid-Q4 2025. LENZ will initiate direct-to-eye care professional sales and marketing activities immediately.
Company Leadership Highlights Milestone
“The FDA approval of VIZZ is a defining moment for LENZ and represents a transformative improvement in the available treatment options for the 128 million adults living with blurry near vision in the United States. We are ready and excited to launch the first and only once-daily eye drop with proven efficacy for up to 10 hours into the market,” said Eef Schimmelpennink, president and chief executive officer of LENZ Therapeutics. “This significant milestone is the result of tremendous commitment and collaboration by the LENZ team and our partners, the dedication of our clinical investigators and the contributions of hundreds of participants in our clinical trials. I want to thank each of them for their role in getting VIZZ FDA approved.”
How VIZZ Works
VIZZ is powered by aceclidine, which features a differentiated mechanism of action as a predominantly pupil-selective miotic that interacts with the iris while causing minimal ciliary muscle stimulation. VIZZ contracts the iris sphincter muscle, resulting in a pinhole effect and a unique sub-2 mm pupil that extends depth of focus and significantly improves near vision without causing a myopic shift. Aceclidine, the sole active ingredient in VIZZ, is a new chemical entity in the United States and its FDA approval marks a global first in presbyopia treatment, according to LENZ.
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Expert Opinion on New Treatment
“This FDA approval represents a disruptive paradigm shift in treatment options for millions of people who are frustrated and struggling with the inevitable age-related loss of their near vision,” said VIZZ clinical investigator Marc Bloomenstein, OD, FAAO, of Schwartz Laser Eye Care Center in Scottsdale, Arizona. “I believe this will be a welcome solution for both optometrists and ophthalmologists who will now be able to offer a highly effective and sought-after presbyopia treatment that could immediately become the standard of care with a product profile that will meet our patients’ needs.”
Clinical Trial Data Supports Approval
The FDA approval of VIZZ was based on results from three randomized, double-masked, controlled Phase 3 studies. CLARITY 1 and CLARITY 2 evaluated the safety and efficacy of VIZZ in 466 participants dosed once daily for 42 days. CLARITY 3 assessed 217 participants for long-term safety over six months of once-daily dosing.
VIZZ achieved all primary and secondary near vision improvement endpoints in both CLARITY 1 and CLARITY 2, demonstrating improvement within 30 minutes and efficacy lasting up to 10 hours. Near vision improvement was reproducible and consistent across both trials. VIZZ was well tolerated, with no serious treatment-related adverse events observed over more than 30,000 treatment days in the three CLARITY trials. The most common reported adverse reactions were installation site irritation, dim vision and headache. Most adverse reactions were mild, transient and self-resolving.
For more information about VIZZ and full prescribing information, please visit www.VIZZ.com.
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